| Primary Device ID | 00850005780168 |
| NIH Device Record Key | 4d33c617-ca4b-4ff7-9d7a-2267895d3291 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GU Tek |
| Version Model Number | UCA5-95 |
| Catalog Number | UCA5-95 |
| Company DUNS | 118877356 |
| Company Name | V L V ASSOCIATES (INC) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005780168 [Primary] |
| EYK | Connector, Ureteral Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2020-07-15 |
| 00850005780168 - GU Tek | 2020-07-23Ureteral Catheter Connecting Adapter |
| 00850005780168 - GU Tek | 2020-07-23 Ureteral Catheter Connecting Adapter |
| B5911425L3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor |
| B5911425M3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor |
| B5911425S3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor |
| B5911425XL3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor |
| B5911425XS3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor |